| Function: | Antineoplastic |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Powder |
| Volatile: | Not Volatile |
| Samples: |
|---|
Suppliers with verified business licenses
Audited Supplier | According to | EP9.0 | |
| Items | Standard | Results |
| Appearance | White or almost white crystalline powder | white crystalline powder |
| Solubility | Slighly soluble in water,very slightly soluble in methanol,practically insoluble in anhydrous ethanol | conforms |
| Identification | Spectrum of sample should be consistent with spectrum of reference standard Specific optical rotation(see Tests) |
Conforms conforms |
| Appearance of Solution | The solution is clear and colorless | conforms |
| Acidity | Dissolve 0.10g in carbon dioxide-free water R,dilute to 50ml with the same solvent and add 0.5ml of phenolphthalein solution R1 ,the solution is colourless.Not more than 0.6ml of 0.01M sodium hydroxide is required to change the colour of the indicator to pink | conform |
| Specific optical rotation(20ºC) | +74.5°~+78.0°(dried substance) | +75.9° |
| Impurity D | ≤0.10% | N.D |
| Related substances | Impurity A≤0.10% Impurity B≤0.10% Impurity C≤0.10% Impurity C:Any other impurity≤0.10% Impurity C:Total of other impurities≤0.10% Total of impurities≤0.30% |
0.01% 0.01% 0.001% 0.003% 0.01% 0.03% |
| Silver | ≤5.0ppm | <1ppm |
| Loss on drying | ≤0.5% | 0.10% |
| Bacterial endotoxins | <1.0IU/mg(1.0EU/mg) | <1.0IU/mg(1.0EU/mg) |
| Residual solvent | Alcohol ≤0.5% | N.D |
| Assay | 98.0%~102.0%(dired substance) | 99.6% |
Suppliers with verified business licenses
Audited Supplier 
){kind=link}
){kind=link}